FDA Device Recall Z-1651-2021

The Biomed Guys · Clarksville, TN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

Lot / serial / GTIN: Serial numbers of serviced devices, serviced 09/2020-02-2021: 12833065, 13187021, 13187811, 12838069, 12982509, 12837231, 12835186, 12837972, 12710593, 12776790, 13753893, 13605919, 12832544, 15763526, 14806203, 14806612, 14807070, 13738432, 15763547, 15865626, 14806472, 12796415,

Quantity: 22 units

Reason for recall

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

Recall record

Recall number: Z-1651-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Us distribution to the states of IN and TX.
Recall initiated: 2021-03-25
Classified by FDA Center: 2021-06-01
FDA published: 2021-06-09
Recalling firm: The Biomed Guys
Firm location: Clarksville, TN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls